[End] Innovation Forum 2023 "Simplification of pDNA|mRNA Manufacturing Process by Sartorius"

New standards for integrity testing machines that comply with the latest data integrity and QRM.

The Zaltcheck series is the most widely used in the pharmaceutical industry and has gained the trust of many users as a proven integrity testing device. The Zaltcheck 5 Plus is the latest model in the series, released in 2019. With new technology, we have further enhanced usability, compliance with the latest regulations, and error detection capabilities. It sets a new standard for integrity testing devices that meets the needs of customers seeking higher levels of testing. 【Main Features of the Product】 ■ Specifications that exceed QRM legal requirements - Automatic detection of test setting errors and abnormal test conditions ■ Highest level of data integrity - Customized Linux OS - Data encryption and dual data backup ■ Intuitive and excellent operability - Large touchscreen with a clear viewing angle and intuitive user interface - First in the series to support Japanese display ■ Achievement of Health, Safety, and Environment (HSE) - Explosion-proof specifications (ATEX IECEx & FM certified) that allow safe testing of alcohol-wetted filters *For more details, please contact us or download the PDF materials.

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Bioreactor system for cell line development and process optimization.

The Ambr1515 Generation 2 is a high-throughput "automated micro-scale bioreactor system" that reproduces the performance of laboratory-scale bioreactors. The system consists of single-use vessels, an automated workstation, and enhanced convenience software. It is designed to be installed in a standard biosafety cabinet for aseptic operations, allowing for parallel monitoring and control of 24 or 48 micro-bioreactor cultures. As the manufacturing processes for biopharmaceuticals become more complex and the density of cultures increases, scientists around the world are facing an unprecedented challenge in developing "clone, medium, and process" that meet new demands. The Ambr15 Generation 2 system enhances equipment performance that influences the success of cultures, improves flexibility, and incorporates new features that reflect user feedback. It helps address the aforementioned challenges and supports the acceleration of research by scientists.

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Introducing options and accessories that can be added to the Ambr 15 Generation 2.

You can find the following information in this catalog: ▪ System specifications ▪ Compatible at-line analyzers ▪ Expandable options ▪ Accessories ▪ Ambr 15 microbioreactor (culture vessel) ▪ Plates and chips

• Other physicochemical equipment
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Single-use culture equipment that meets the requirements of the microbial culture process.

【Advantages】 ▪ Specifications designed to accommodate all microbial culture processes ▪ Production of plasmid DNA ▪ Microbial culture bags that have undergone qualification for GMP manufacturing ▪ Improved productivity and user-friendly ▪ Refined process control proven in cell culture

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Rapid at-line analysis chromatography solution

【Features】 ▪ High-speed, high-resolution HPLC analysis for pDNA processes ▪ Acceleration of PD and stabilization of manufacturing and quality through at-line monitoring ▪ Ability to obtain a lot of important information in a short time, with low effort and low cost ▪ Unique monolithic column for CIMac pDNA analysis ▪ User guide, dedicated validated methods, SOPs, and standard materials included

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Fully automated tangential flow filtration system using a closed-loop single-use system suitable for process development to pilot-scale manufacturing.

**Features** - Single-use TFF specifically designed for 1 to 20L scale, providing cost-effective solutions from process development to pilot. - Ready-to-use and closed system, resulting in low bio-burden risk. **Characteristics in ADC Manufacturing** - Automation of three processes: ADC synthesis, precipitate removal, and TFF within a single system. - Reduction of funding, labor, installation space, and process risks, enabling a seamless transition from process development to small-scale commercial ADC manufacturing. - Flexible process sequence control allows for compatibility with various ADC manufacturing protocols. - Stirring optimized for minimal capacity with temperature control.

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Technology for clarification of cell cultures and removal of impurities: Sartoclear Depth Filter

The Zaltclear Depth Filter product family is a cellulose-based filter that contains diatomaceous earth. It is used in the biotechnology and pharmaceutical industries, where high solid removal capabilities are required to meet strict standards. In a dual-layer (DL) format, it can filter cell culture media with a cell density of less than 15×10⁶/mL from the process development stage to the commercial production stage.

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Please check the Japanese version catalog for a significant increase in operability and stirring power!

A high-speed, flexible, and intelligent single-use mixer that accommodates all stirring processes in cGMP-compliant bioprocessing. In mixing processes within the bioprocess environment, quality and efficiency are critically important, and the choice of mixing equipment has a dramatic impact on both. A high-speed, flexible single-use mixer enhances manufacturers' competitiveness and improves productivity.

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A robust, complete, and scalable solution for frozen storage and frozen transportation.

Based on over 15 years of experience in the design of single-use freezing and thawing solutions, we have established Celsius pre-design solutions (PDS) for all processes requiring frozen storage and frozen transport, at both lab scale and manufacturing scale. Celsius PDS separates the downstream process and is equipped with the necessary functions for the safe transport of active pharmaceutical ingredients to pharmaceutical manufacturing facilities.

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Smart condition setting, a genuine end-to-end integrated freeze-thaw system.

A robust, complete, and scalable solution for frozen storage and frozen transport. Sartorius offers lab-scale Celsius solutions for smarter and earlier process decisions in the management of frozen active pharmaceutical ingredients. The Celsius Lab-scale Platform enables the characterization of freezing and thawing within single-use bags of 30 mL to 100 mL, featuring complete scalability up to the commercial-scale Celsius Platform (CFT, FFT, and FFTP).

• Other physicochemical equipment
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Freeze-thaw solutions for seamless scalability to commercial production.

Sartorius, with over 15 years of experience in the design of freeze-thaw solutions, offers lab-scale and manufacturing-scale solutions for all steps of processes requiring frozen storage and frozen transport. This enables biopharmaceutical manufacturers to effectively decouple downstream processes and safely transport active pharmaceutical ingredients to drug manufacturing facilities. The Celsius Platform, equipped with options for blast freezers, horizontal freezers, and vertical plate freezers, provides an end-to-end integrated approach that enables monitoring and control to broadly ensure product quality and integrity.

• Other physicochemical equipment
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We would like to extend our heartfelt congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will showcase a variety of products, including new ones. We sincerely invite you to visit us during this busy time. 【 Exhibition Name 】 Automotive Technology Exhibition 2025 YOKOHAMA https://aee.expo-info.jsae.or.jp/ja/yokohama/ (An "online exhibition" will also be held during and around the event period) 【 Dates 】 May 21 (Wednesday) - 23 (Friday), 2024 10:00 AM - 6:00 PM *On the final day, 9:00 AM - 4:00 PM (Online exhibition: May 14 (Wednesday) - June 4 (Wednesday)) 【 Venue 】 Pacifico Yokohama (1-1-1 Minatomirai, Nishi-ku, Yokohama, Kanagawa Prefecture) Our booth number: "Concourse 505"

We would like to extend our heartfelt congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will showcase a variety of products, including new ones. We sincerely apologize for the inconvenience during your busy schedule, but we would like to invite you to attend this event. 【 Exhibition Name 】 27th INTERPHEX Week Tokyo https://www.interphex.jp/tokyo/ja-jp.html 【 Dates 】 July 9 (Wednesday) - 11 (Friday), 2025 10:00 AM - 5:00 PM 【 Venue 】 Tokyo Big Sight (3-11-1 Ariake, Koto-ku, Tokyo 135-0063)

Nitto Kohki will exhibit at the "H₂ & FC EXPO Spring International Hydrogen and Fuel Cell Exhibition" held at Tokyo Big Sight, West Exhibition Hall 2, from February 28 (Wednesday) to March 1 (Friday), 2024. [Booth Number: W14-63] The quick fluid coupling "Coupler" is a product that allows for the rapid connection and disconnection of piping for various fluids such as air, water, oil, and chemical solutions. At this exhibition, we will primarily showcase the high-pressure hydrogen filling quick fluid coupling "HHV Coupler."

Nitto Kohki will exhibit at the "22nd H₂ & FC EXPO Autumn International Hydrogen and Fuel Cell Exhibition" held at Makuhari Messe Hall 8 from October 2 (Wednesday) to October 4 (Friday). [Booth Number: E22-14] The rapid fluid connector "Coupler" is a product that allows for quick connection and disconnection of piping for various fluids such as air, water, oil, and chemical solutions. At this exhibition, we will primarily showcase the high-pressure hydrogen filling rapid fluid connector "HHV Coupler."

Nitto Kohki will hold the "2025 Attack Fair in Meiko" for two days from July 23 (Wednesday) to July 24 (Thursday), 2025, at the "Kowa Seminar Plaza 2F Training Room NO.12 (inside Kowa Sports Land)." The Attack Fair is an exhibition where you can actually "see, touch, and operate" Nitto Kohki's products. Additionally, there will be wonderful souvenirs for attendees and many fun activities planned. We look forward to welcoming everyone!